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TECHNICAL STANDARD Radiographic Fluoroscopic Equipment / 1

The American College of Radiology, with more than 30,000 members, is the principal organization of radiologists, radiation oncologists, and clinical

medical physicists in the United States. The College is a nonprofit professional society whose primary purposes are to advance the science of radiology,

improve radiologic services to the patient, study the socioecono mic aspects of the pr actice of r adiology, and encour age continuing education for

radiologists, radiation oncologists, medical physicists, and persons practicing in allied professional fields.

The American College of Radiology will periodically define new practice parameters and technical standards for radiologic pract ice to help adva nce the

science of radiology and to improve the quality of service to patients throughout the United States. Existing practice parameters and technical standards

will be reviewed for revision or renewal, as appropriate, on their fifth anniversary or sooner, if indicated.

Each practice parameter and technical standard, representing a policy statement by the College, has undergone a thorough consensus process in which it has

been subjected to extensive review and approval. The practice parameters and technical standar ds recognize that the safe and ef fective use of diagnostic

and therapeutic radiology requires specific training, skills, and techniques, as desc ribed in each document. Reproduction or modification of the published

practice parameter and technical standard by those entities not providing these services is not authorized.

Revised 2011 (Resolution 4)*

ACR TECHNICAL STANDARD FOR DIAGNOSTIC MEDICAL PHYSICS

PERFORMANCE MONITORING OF RADIOGRAPHIC AND FLUOROSCOPIC

EQUIPMENT

PREAMBLE

This document is an educational tool designed to assist practitioners in pr oviding appropriate radiologic care for

patients. Practice Parameters and Technical Standards are not inflexible rules or requirements of practice and are

not intended, nor should they be used, to establish a legal standard of care1. For these reasons and those set forth

below, the American College of Radiol ogy and our collaborating medical specialty societies caution against the

use of these documents in litigation in which the clinical decisions of a practitioner are called into question.

The ultimate judgment regarding the propriety of any specific procedure or course of action must be made by the

physician or medical physicist in light of all the circumstances presented. Thus, an approach that differs from the

guidelines, standing alone, does not nec essarily imply that the approach was below the st andard of care. To the

contrary, a conscientious practitioner may responsibly adopt a course of action different from that set forth in theguidelines when, in the reasonable judgment of the practitioner, such course of action is indicated by the condition

of the patient, lim itations of available resources, or advances in knowledge or technology subsequent to

publication of the guidelines. However, a practitioner who employs an approach substantially different from these

guidelines is advised to document in the patient record information sufficient to explain the approach taken.

The practice of medicine involves not only the science, but also the art of dealing with the prevention, diagnosis,

alleviation, and treat ment of disease. The variety and complexity of hum an conditions make it impossible to

always reach the most appropriate diagnosis or to pred ict with certainty a particular response to treat ment.

Therefore, it should be recognized that adherence to these guidelines will not assure an accurate diagnosis or a

successful outcome. All that should be expected is t hat the practitioner will follow a reasonable course o f action

based on current knowledge, available resources, and the needs of the patient to deliver effective and safe medical

care. The sole purpose of these guidelines is to assist practitioners in achieving this objective.

1 Iowa Medical Society and Iowa Society of Anesthesiologists v. Iowa Board of Nursing, ___ N.W.2d ___ (Iowa 2013) Iowa Supreme Court refuses to find

that the ACR Technical Standard for Management of the Use of Radiation in Fluoroscopic Procedures (Revised 2008) sets a national standard for who may

perform fluoroscopic procedures in light of the standard’s stated purpose that ACR stan dards are educational tools and not intended to establish a legal

standard of care. See also, Stanley v. McCarver, 63 P.3d 1076 (Ariz. App. 2003) where in a concurring opinion the Court stated that “published standards or

guidelines of specialty medical organizations are useful in determining the duty owed or th e standard of care applicable in a g iven situation” even though

ACR standards themselves do not establish the standard of care.


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2 / Radiographic Fluoroscopic Equipment TECHNICAL STANDARD

I. INTRODUCTION

This technical standard w as revised by the Ameri can College of Radiology (ACR) with assistance from the

American Association of Physicists in Medicine (AAPM).

The performance of all radiographic and fluoroscopic equipment must be evaluated upon installation and

monitored at least annually by a Qualified Medical Physicist to ensure that the equipment is functioning properly

and that patients are not exposed to unneces sary doses of radiation. Additional or more frequent monitoring may

be necessary after r epairs that might change the radiation exposure to pa tients or perso nnel or the imaging

performance of the eq uipment. Although it is n ot possible to c onsider all p ossible variations of equipment performance to be monitored, adherence to this technical standard will assi st in maximizing image quality and in

reducing patient radiation doses.

II. GOAL

The goals are to produce the highest quality diagnostic image at the lowest reasonable radiation dose consistent

with the clinical use of the equipment and the information requirement of the examination and to establish and

maintain performance standards.

III. QUALIFICATIONS AND RESPONSIBILITIES OF PERSONNEL

A Qualified Medical Physicist is an individual who is co mpetent to practice independentl y one or m ore of thesubfields in medical physics. The A merican College of Radiology (ACR) considers certification, cont inuing

education, and experience in the appropriate subfield(s) to demonstrate that an individual is competent to practice

one or more of the subfields in medical physics, and to be a Qu alified Medical Ph ysicist. The ACR strongl y

recommends that the indi vidual be certified in the ap propriate subfield(s) by the American Board of Radiology

(ABR), the Canadian College of Physics in Medicine, or by the American Board of Medical Physics (ABMP).

A Qualified Medical Physicist should meet the ACR Practice Guideline for Continuing Medical Education

(CME). (ACR Resolution 17, 1996 – revised in 2012, Resolution 42)

The appropriate subfield of medical physics for this technical standard is Diagnostic Medical Phy sics. (Previous

medical physics certification including Radiological Phy sics, Diagnostic Radiological Ph ysics, and Diag nostic

Imaging Physics are also acceptable.)

Understanding of the relationship between i mage quality and patient radiation dose is essential for proper

monitoring of equipment performance. The medical physicist must be fam iliar with the principles of i maging

physics and radiation protection; the current guidelines of the National Council on Radiation Protection and

Measurements (NCRP); federal and local laws and regula tions pertaining to the performanc e of the equipment

being tested; the function, clinical uses, and performance specifications of the imaging equipment; and calibration

processes and limitations of the instruments used for testing performance.

The medical physicist may be assisted by other properly trained individuals in obtaining test data for performance

monitoring. These individuals must be properly trained and approved by the medical physicist in the techniques of

performing the tests, the function and li mitations of the imaging equipment and test instruments, the reasons for

the tests, and the importance of the test results. The tests will be performed by or under the general supervision ofthe medical physicist, who is responsible for and must review, interpret, and approve all data and provide a signed

report.

IV. PERFORMANCE CHARACTERISTICS TO BE MONITORED

A. Performance Evaluation

The performance of each r adiographic and fluoroscopic unit must be evaluated at least annually. This evaluation

should include, but not be limited to, the following tests (as applicable):

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1. Integrity of unit assembly.

2. Collimation and radiation beam alignment.

3. Fluoroscopic system resolution.

4. Automatic exposure control system performance.

5.

Fluoroscopic automatic b rightness control performan ce (high-dose-rate, pulsed modes, field-of-view

[FOV] variation).

6. Image artifacts.

7. Fluoroscopic phantom image quality.

8.

kVp accuracy and reproducibility.9.

Linearity of exposure versus mA or mAs.

10. Exposure reproducibility.

11. Timer accuracy.

12. Beam quality assessment (half-value layer).

13. Fluoroscopic entrance exposure rates.

14.

Image receptor entrance exposure.

15. Equipment radiation safety functions.

16. Patient dose monitoring system calibration

17. Video and digital monitor performance.

18. Digital image receptor performance.

For further inform ation on com puted radiography [CR] and digital radiogra phy [DR] systems please see th eACR–AAPM–SIIM Practice Guideline for Digital Radiography [1].

B. Quality Control Program

A continuous quality control (QC) program must be implemented for all radiographic and fluoroscopic units. The

program should be established with t he assistance of the medical physicist. The medical physicist should identify

the person responsible for performing the tests and may choose to modify the frequency of testing based on t he

system’s usage and performance. The QC program should include, but not be lim ited to, the following tests (asapplicable):

1. Appropriateness of technique factors.

2.

Visual equipment checklists.3. Phantom images.

4. Repeat analysis.

5. Viewboxes, image monitors, and viewing conditions.

6. Laser film printer quality control.

7.

Darkroom and screen cleanliness.

8. Processor quality control.

9. Screen film speed matching.

10. Analysis of fixer retention.

11. Darkroom fog.

12.

Screen-film contact.

13. CR and DR system performance.

C. Acceptance Testing

Initial performance testing of imaging equipm ent must be performed upon installation and before clinical use.

This testing must be more comprehensive than pe riodic performance and m ust be consistent with curren t

acceptance testing practices. Electrical safety of the equipment must also be tested by appropriate personnel prior

to its initial clinical use.

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D. Written Survey Reports and Follow-Up Procedures

The medical physicist must provide a written report of the findings of acceptance test ing and performance

evaluation to the responsi ble physician(s), if appropriate, a nd to the professional(s) in charge of obtaining or

providing necessary service to the equipment. If appropriate, the medical physicist should initiate the required

service. Written reports must be provided in a timely manner consistent with the im portance of any adverse

findings.

If use of the equipm ent would pose imm inent danger to patients or staff, the m edical physicist must take

immediate action to prevent its use.

V. RADIATION SAFETY IN IMAGING

Radiologists, medical physicists, regist ered radiologist assistants, radiologic technologists, and all supervisin g

physicians have a responsibility for safety in the workplace by keeping radiation exposure to staff, and to society

as a whole, “as low as reasonably achievable” (ALARA) and to assure that radiation doses to individual patients

are appropriate, taking into account the possible risk from radiation exposure and the diagnostic image quality

necessary to achieve the clinical objec tive. All personnel that wor k with ionizing radiation must understand the

key principles of occupat ional and public radiation protection (justification, optimization of protection and

application of dose limits) and the pri nciples of proper management of radiation d ose to patients (justification,

optimization and the use of dose refere nce levels) http://www-

pub.iaea.org/MTCD/Publications/PDF/p1531interim_web.pdf

Nationally developed guidelines, such as the ACR’s Appropriateness Criteria®, should be used to help choose the

most appropriate imaging procedures to prevent unwarranted radiation exposure.

Facilities should have and adhere to po licies and procedures that require varying ionizing radiation exam ination

protocols (plain radiography, fluoroscopy, interventional radiology, CT) to take into account patient body habitus

(such as patient dimensions, weight, or body mass index) to optimize the relationship between minimal radiation

dose and adequate image quality. Automated dose reduction technologies available on imaging equipment should be used whenever appropriate. If such technology is not available, appropriate manual techniques should be used.

Additional information regarding patie nt radiation safety in i maging is avai lable at the Image Gently® for

children (www.imagegently.org) and I mage Wisely® for adults ( www.imagewisely.org) websites. Theseadvocacy and awareness campaigns provide free educational materials for all stakeholders involved i n imaging

(patients, technologists, referring providers, medical physicists, and radiologists).

Radiation exposures or other dose i ndices should be measured and patient radiation dose estimated for

representative examinations and types of patients by a Qualified Medical Phy sicist in accordance with the

applicable ACR technical standards. Regular auditing of patient dose indices should be performed by comparing

the facility’s dose information with national benchmarks, such as the ACR Dose Index Registry, the NCRP

Report No. 172, Reference Levels and Achievable Doses in Medical and Dental Imaging: Reco mmendations for

the United S tates or the Conference of Radiation Control Program Director’s National Evaluation of X-ray

Trends. (ACR Resolution 17 adopted in 2006 – revised in 2009, 2013, Resolution 52).

Patient radiation dose must be estimated for radiographic and fluoroscopic equipment at least annually. Tables of patient radiation exposure for representative examinations must be prepared and supplied to the facility. These

tables must be prepared using m easured radiation output data and imaging techniques provided by the facility.

These results must be compared with appropriate guide lines or recommendations when they are available [2-3 ].

The medical physicist should assist facilities in understanding and developing policies and procedures to evaluate

risks to patients, personnel, and physicians from studies and interventions requiring prolonged radiation exposure

[3-13].


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ACKNOWLEDGEMENTS

This technical standard was revised according to the pro cess described under the hea ding The Process for

Developing ACR Practice Parameters and Technical Standards on t he ACR website

(http://www.acr.org/guidelines) by the Committee on Practice Parameters and Technical Standards of the

Commission on Medical Physics with assistance from the AAPM.

Principal Reviewers

Mahadevappa Mahesh, MS, PhD, FACR

John M. Boone, PhD, FACR

Committee on Practice Parameters and Technical Standards– Medical Physics

(ACR Committee responsible for sponsoring the draft through the process)

Richard A. Geise, PhD, FACR, Chair

Tariq A. Mian, PhD, FACR, Vice Chair

William K. Breeden, III, MS

Laurence E. Court, PhD

Martin W. Fraser, MS

Nicholas J. Hangiandreou, PhD

Bruce E. Hasselquist, PhD

Ralph P. Lieto, MSMahadevappa Mahesh, MS, PhD, FACR

James T. Norweck, MS

Janelle L. Park, MDDoug Pfeiffer, MS

Gerald A. White, Jr., MS, FACR

James M. Hevezi, PhD, FACR, Chair, Commission

REFERENCES

1. American College of Radiology . Practice guideline for digital radiography . http://www.acr. org/

SecondaryMainMenuCategories/quality_safety/guidelines/dx/digital_radiography.aspx. Accessed May 24,

2011.2. American College of Radiology. Practice guideline for diagnostic reference levels in medical x-ray imaging.

http://www.acr.org/SecondaryMainMenu

Categories/quality_safety/guidelines/med_phys/reference_levels.aspx. Accessed May 24, 2011.

3. Public Health Advisory: Avoidance of Serious X-Ray Induced Skin Injuries to Patients During

Fluoroscopically-Guided Procedures. Rockville, Md: Food and Drug Administration; 1994.

4. Specification and Acceptance Testing and Quality Assurance of Diagnostic X-Ray Imaging Equipment.

College Park, Md: American Association of Physicists in Medicine; 1994. AAPM Monograph 20.

5. Managing the Use of Fluoroscopy in Medical Institutions. College Park, Md: Americ an Association of

Physicists in Medicine; 1998. AAPM Report 58.

6. Cardiac Catheterization Equipment Performance. College Park, Md: American Association of Physicists in

Medicine; 2001. AAPM Report 70.

7. Structural Shielding Design for Medical X-Ray Imaging Facilities. Bethesda, Md: National Counci l onRadiation Protection and Measurements; 2004. NCRP Report 147.

8. Performance Standards for Diagnostic X-Ray Systems and their Major Components: Federal Register; June

10, 2005. Final Rule 21 CFR Part 1020.30-1020.32.

9. Balter S, Ho pewell JW, Miller DL, Wagner LK, Ze lefsky MJ. Fluoroscopically guided interventional

procedures: a review of radiation effects on patients' skin and hair. Radiology 2010;254:326-341.

10. Mahesh M. Fluoroscopy: patient radiation exposure issues. Radiographics 2001;21:1033-1045.

11. Miller DL, Balter S, Wagner LK, et al. Quality improvement guidelines for recording patient radiation dose in

the medical record. J Vasc Interv Radiol 2009;20:S200-207.


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12. Seibert JA, Filipow L, Andriole K, ed. Practical Digital Imaging and PACS . Madison, Wisc: Medical Physics

Publishing; AAPM Monograph 25; 1999.

13. Stecker MS, Balter S, Towbin RB, et al. Gu idelines for patient radiation dos e management. J Vasc Interv

Radiol 2009;20:S263-273.

*Practice parameters and technical standards are publishe d annually with an effective date of October 1 in the

year in which am ended, revised or approved b y the ACR Council. For practice parameters and technical

standards published before 1999, the e ffective date was January 1 foll owing the y ear in which the practice

parameters or technical standard was amended, revised, or approved by the ACR Council.

Development Chronology for this Technical Standard

1992 (Resolution 11)

Amended (Resolution 13)

Revised 1997 (Resolution 17)


Revised 2006 (Resolution 29, 16g, 17)

Amended 2009 (Resolution 11)


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